Slotted ocular lens

This application claims the benefit of U.S. Provisional Application No. 63/245,120, filed Sep. 16, 2021, the disclosure of which is hereby incorporated by reference.

The present disclosure provides examples of a lens suitable for use in ophthalmic procedures. In some examples, the lens is suitable for use as a laser suture lysis lens.

Replacement of one's natural lens with an interocular lens (IOL) implant is well known to address problems associated with cataracts. Cataract surgery usually involves making one or more small incision near the edge of the cornea. The surgeon uses these incisions to reach the natural lens of the eye. Using very small instruments, the surgeon removes the cataracted lens and replaces it with the IOL. In some instances, these small incisions are left to heal naturally. In other cases, a few sutures may be used to close the small incisions to aid in the healing process.

In some cases, larger incisions may be required during cataract surgery. For example, some IOL are rigid and not foldable. As a result, the larger incision allows for easier placement of the IOL. With these larger incisions, several sutures are typically required for closure. In some procedures, typically if the patient is experiencing other eye conditions, the natural (cataracted) lens is removed in one piece via a procedure called extracapsular cataract extraction. This procedure also requires a larger incision, and typically larger than that used for a procedure known as phacoemulsification, which uses ultrasound to break up the natural lens for removal. Again, with these larger incisions, several sutures are typically required for closure.

Other surgical procedures of the eye may require sutures. One such procedure is trabeculectomy. Trabeculectomy is a type of glaucoma surgery performed on the eye that creates a new pathway for fluid inside the eye to be drained. When performing trabeculectomy, a surgeon creates a flap in the conjunctiva as well as the sclera—the white part of the eye—underneath the upper eyelid. Underneath the scleral flap, a pathway is created to allow fluid to drain, which lowers eye pressure. The flap is then placed loosely back down against the sclera to protect the drainage pathway. One or more sutures may be employed to maintain the scleral flap post-surgery. The conjunctiva flap may also be retained with one or more sutures.

Some complications to these aforementioned procedures may include increased eye pressure, suture-induced astigmatism, etc. It is well known to remove one or more of the tight sutures post-surgery to address these issues or others. In other cases without these complications, the tight sutures may need to be removed several weeks after surgery.

Another trabeculectomy procedure of the eye that requires sutures involves the use of a glaucoma drainage implant. A drainage implant (also called an aqueous shunt or tube shunt) creates a new path for aqueous humor to drain from the eye. In this procedure, the surgeon makes a pocket under the conjunctiva. The plate of the implant is then placed in this pocket, supported by the sclera. The drainage implant includes a tiny drainage tube attached to the plate. The drainage tube is inserted into the anterior chamber of the eye. Aqueous fluid flows out of the eye through this drainage tube, lowering the eye pressure. The fluid collects in a pool over the plate (called a reservoir or bleb). This fluid is absorbed naturally by the body over time.

In order to remove the sutures, one procedure that surgeons may perform is laser lysis. Suture lysis by laser is usually preferred to surgical suturotomy. Serious complications such as endophthalmitis, epithelial defect, flat anterior chamber, subconjunctival hemorrhage, and hyphaema can occur after surgical suturotomy. With laser suture lysis, a lysis lens is employed to assist the surgeon in locating the sutures and for providing a complete visualization of the surgical site so that laser energy can be directed onto the sutures. The lysis lens also functions to mechanically prevent eye blinking and to apply gentle pressure against the conjunctiva in suture removal after trabeculectomy. Compression of the conjunctiva onto the scleral surface causes deturgescence and blanching of the conjunctiva allowing a clear visualization of the suture to be lysed.

In trabeculectomy or other procedures when using non-valved drainage implants, such as the Molteno-type or Baerveldt-type drainage implant, the surgeon typically occludes the drainage tube with an absorbable or meltable suture. The reason for the occlusion is to avoid early post-operative hypotony (low pressure), which can occur without the formed capsule around the drainage implant.

Postoperatively this ligature may not break or be able to be lysed in a predictable manner leaving a patient with very high intraocular pressure or it may break unattended with a patient on full glaucoma medications producing a very low intraocular pressure. This very low intraocular pressure may produce vision threatening conditions such as choroidal effusions or choroidal hemorrhage. Therefore, control over this ligature release time is imperative to post-operative patient safety.

Examples of the lens of the present disclosure aim to address lysing this ligature or other sutures.

1 5 FIGS.- 20 20 is an example of an ocular lens, such as a laser lysis lens, generally designated, according to an aspect of the present disclosure. The laser lysis lensis suitable for use in viewing and lysing sutures in ophthalmic procedures.

1 4 FIGS.- 20 24 24 24 28 28 28 As shown in, the laser lysis lensincludes an elongate handleto be gripped by the surgeon during use. The handlemay include one or more ergonomic features. At one end of the handlethere is disposed a lens body. In an embodiment, the lens bodyis transparent or substantially translucent. In this or other embodiments, the lens bodyis configured to provide the surgeon with a lens magnification, for example 2× lens magnification.

3 5 FIGS.- 3 4 FIGS.and 28 32 36 36 24 40 44 48 28 As shown in, the lens bodyincludes a bulbous upper portionand a multi-faceted lower portion. In the embodiment shown in, the multi-faceted lower portionincludes a number of faces or facets, such as first and second forward facing (with respect to the handle) facetsand, and an eye contacting facetdisposed at the bottom of the lens body. The term “eye contacting” is used herein to mean contacting the surface of the eye, including the cornea, the conjunctiva, the sclera, etc.

40 44 28 24 40 44 50 50 24 4 6 FIGS.and 4 FIG. The first and second facetsandadjoin forwardly at either a centralized forward edge or at a facet of the lens body, opposite of the handle. In the embodiment shown in, the forward portions of the first and second facetsandadjoin at a centralized forward facetof somewhat triangular shape. In an embodiment, the centralized forward facetis aligned with the longitudinal axis of the handle, as shown in.

28 52 56 58 40 44 40 44 40 44 48 3 4 5 FIGS.,, and 3 6 FIGS.and The lens bodyfurther includes a semi-circular wall surfacethat extends rearwardly from the rear edgesandof the first and second facetsand, respectively, as shown in. In an embodiment, the first and second facetsandare orientated at an angle with respect to one another in order to manipulate patient eye lids, allow for smaller size or narrower fissures, etc. Each of the first and second facetsandis also orientated at an angle with respect to the eye contacting facetas shown in.

4 FIG. 48 64 66 70 64 50 64 70 76 78 40 44 66 48 80 52 In the embodiment shown in, the eye contacting facetincludes a triangular portionthat adjoins a semi-circular portionat an interface to form a somewhat teardrop shape. In the amendment shown, the tipof the triangular portionis delineated by the bottom of the forward facet. The sides of the triangular portionextending from the tipare formed by the bottom edgesandof the first and second facetsand, respectively. Similarly, the semi-circular portionof the eye contacting facetis delineated by the bottom arcuate edgeof the semi-circular wall surface.

48 20 48 In use, the teardrop shaped eye contacting facetforms auxiliary lysis zones. When the lensis used in laser lysis, the eye contacting facetcreates focal high-pressure zones that thin tissue (e.g., conjunctiva, etc.) and aid visualization. In some embodiments, the pressure applied by the lens compresses the conjunctiva against the sclera. This compression causes deturgescence and blanching of the conjunctiva, allowing a clear visualization of the suture to be lysed.

28 84 48 84 66 48 64 48 40 44 84 84 20 84 24 4 5 FIGS.and 4 5 FIGS.and In accordance with an aspect of the present disclosure, the lens bodyincludes a polished groove or elongated slotdisposed in the eye contacting facet, as shown in. In the embodiment shown in, the slotis orientated so as to form an interface that adjoins the semi-circular portionof eye contacting facetwith the triangular portionof the eye contacting facet. In an embodiment, the first and second angled facetsandare synchronized to the position of the slotso that during use the eye lids of the patient are held horizontally and the slotis oriented superotemporally where 90%+ of trabeculectomy shunts are placed. With this arrangement, the lenscan be used with either the right hand or the left hand of the surgeon. In some embodiments, the slotis positioned transverse with, and in a certain embodiment approximately orthogonal with, the longitudinal axis of the handle.

84 In some embodiments, the slotis configured to facilitate fixation over, for example, a previously implanted Molteno or Baerveldt-type drainage implant. As briefly described above, drainage implant devices function by promoting simple passive diffusion of fluid out of a collection compartment. When placing the drainage implant in-situ, most of the implant device is positioned on the outside of the eye (toward the back of the eye) under the conjunctiva. A drainage device, which can be a small tube or filament, of the drainage implant, is then carefully inserted into the front chamber of the eye, just in front of the iris. Fluid from the eye drains through the drainage tube, or along the filament, into the area around the back end of the drainage implant. Collected fluid is then reabsorbed by the body.

In trabeculectomy or other procedures when using non-valved drainage implants, such as the Molteno-type or Baerveldt-type drainage implant, the surgeon typically occludes the drainage tube with an absorbable or meltable suture. The reason for the occlusion is to avoid early post-operative hypotony (low pressure), which can occur without the formed capsule around the drainage implant. Postoperatively this ligature may not break or be able to be lysed in a predictable manner, leaving a patient with very high intraocular pressure.

20 84 84 84 20 84 84 84 84 48 88 84 90 20 7 FIG. During suture removal post-operative drainage implant surgery, the lens, because of the configuration and positioning of the slot, is capable of straddling the ligated drainage tube of the drainage implant (e.g., the ligated drainage tube is at least partially received within the slotwhen the drainage tube aligned longitudinally with the slot), thereby permitting a more stable placement of the lensduring laser suture lysis. In other words, the slotallows the surgeon to localize and fixate the drainage tube, which can be poorly seen through post-operative tissue opacities. The slotalso thins eye tissues by direct pressure once the drainage tube is fixated to enhance laser lysis. Once fixated (e.g., between the inner surface of the slotand the eye), the drainage tube extends along the elongated slot. At the same time, the eye contacting facet, or portions thereof, may contact the eyeas the slotsecures or fixates the drainage tubewith respect to the lens, as shown in the embodiment of.

84 84 84 84 84 20 In some embodiments, the slotis rounded with a radius slightly in excess of the radius of the aqueous drainage tube of the implant to accommodate the surrounding tissue. In other embodiments, the radius is slightly less than the radius of the aqueous drainage tube of the implant. In some embodiments, the ratio of the depth of the slotto the radius of the slotis in the range of approximately 0.35:1.0 to approximately 0.40:1.0. In an embodiment, the slotis configured to receive, or at least partially receive, the drainage tube of a Molteno-type or a Baerveldt-type drainage implant. Of course, the slotof the lensmay be configured to fixate the drainage tube of any currently existing or future developed drainage implant or similar medical device.

84 90 84 40 44 24 20 36 In the embodiment shown, the rounded slotacts as a mechanical receptor for localization and fixation of the drainage tubeunder the post-operative tissues and allows the surgeon to cut the suture with a laser. As described briefly above, the slotis oriented with respect to the angled facetsandas well as the handleto be ambidextrous and allow access to drainage implants in the superior and temporal quadrant. In other embodiments, the lens, for example the lower portion, may include four bevels or facets, the arrangement of which would then allow access to drainage implants in the superior and nasal quadrants.

The detailed description set forth above in connection with the appended drawings, where like numerals reference like elements, are intended as a description of various embodiments of the present disclosure and are not intended to represent the only embodiments. Each embodiment described in this disclosure is provided merely as an example or illustration and should not be construed as preferred or advantageous over other embodiments. The illustrative examples provided herein are not intended to be exhaustive or to limit the disclosure to the precise forms disclosed. Similarly, any steps described herein may be interchangeable with other steps, or combinations of steps, in order to achieve the same or substantially similar result. Moreover, some of the method steps can be carried serially or in parallel, or in any order unless specifically expressed or understood in the context of other method steps.

In the aforementioned description, specific details are set forth to provide a thorough understanding of exemplary embodiments of the present disclosure. It will be apparent to one skilled in the art, however, that the embodiments disclosed herein may be practiced without embodying all of the specific details. In some instances, well-known process steps have not been described in detail in order not to unnecessarily obscure various aspects of the present disclosure. Further, it will be appreciated that embodiments of the present disclosure may employ any combination of features described herein.

The present application may reference quantities and numbers. Unless specifically stated, such quantities and numbers are not to be considered restrictive, but exemplary of the possible quantities or numbers associated with the present application. Also, in this regard, the present application may use the term “plurality” to reference a quantity or number. In this regard, the term “plurality” is meant to be any number that is more than one, for example, two, three, four, five, etc. The term “about,” “approximately,” etc., means plus or minus 5% of the stated value.

Throughout this specification, terms of art may be used. These terms are to take on their ordinary meaning in the art from which they come, unless specifically defined herein or the context of their use would clearly suggest otherwise.

The principles, representative embodiments, and modes of operation of the present disclosure have been described in the foregoing description. However, aspects of the present disclosure, which are intended to be protected, are not to be construed as limited to the particular embodiments disclosed. Further, the embodiments described herein are to be regarded as illustrative rather than restrictive. It will be appreciated that variations and changes may be made by others, and equivalents employed, without departing from the spirit of the present disclosure. Accordingly, it is expressly intended that all such variations, changes, and equivalents fall within the spirit and scope of the present disclosure as claimed.